UMIN-CTR Clinical Trial

Basic information
Public title	Stability of brain activation in primary sensory area generated by tactile stimulation in extremities.
Acronym	Stability of activation in primary sensory area
Scientific Title	Stability of brain activation in primary sensory area generated by tactile stimulation in extremities.
Scientific Title:Acronym	Stability of activation in primary sensory area
Region	Japan

Condition
Condition	Normal subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to analyze the relation of the somatotopic plasticity and tactile function by using fMRI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluating point is the temporal difference in activated brain area when upper and lower limb are tactile stimulated. Evaluating point is the matching degree of the activated brain area and anatomical area.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Sensory stimulation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	40 years-old >
Gender	Female
Key inclusion criteria	Healthy females
Key exclusion criteria	1. history of severe systematic / CNS disease. 2. Drug and/or alcoholic abuse. 3. Not adaptable for MRI scanning (e.g. metallic devices, claustrophobia, nyctophobia) 4. Operator's decision as not suitable for this study.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Takayuki Middle name Last name Obata
Organization	National Institutes for Quantum and Radiological Science and Technology National Institute of Radiological Sciences
Division name	Department of Molecular Imaging and Theranostics
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku, Chiba-shi
TEL	043-206-3230
Email	obata.takayuki@qst.go.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Sugiyama
Organization	National Institutes for Quantum and Radiological Science and Technology
Division name	Department of Molecular Imaging and Theranostics
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku, Chiba-shi
TEL	043-206-3230
Homepage URL
Email	sugiyama.satoshi@qst.go.jp

Sponsor
Institute	National Institutes for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization	Ministry of Education, Culture Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Secretariat of the Clinical Research Review Committee
Address	4-9-1 Anagawa, Inage-ku, Chiba-shi
Tel	043-206-4709
Email	helsinki@qst.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 06 Month 03 Day
Date of IRB	2019 Year 06 Month 06 Day
Anticipated trial start date	2019 Year 06 Month 17 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 13 Day
Last modified on	2022 Year 06 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042148